Sustaining Remission From PTSD Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy
This supportive care single-group study (n=200) will test whether regular use of the Apollo wearable (TVS) improves sustained remission rates from PTSD following MDMA-assisted psychotherapy.
Detailed Description
This single-group supportive care study provides an Apollo wearable (transcutaneous vibratory stimulation, 10–200 Hz) to participants who completed MAPS MDMA‑assisted psychotherapy to assess effects on PTSD symptoms, mood, anxiety and emotion regulation.
Participants receive the device and app, are instructed to use it daily (≥30 minutes morning and evening), and complete monthly online questionnaires for two years. The study is independent of MAPS.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
Apollo wearable
experimentalParticipants who completed MAPS MDMA‑assisted psychotherapy will use the Apollo wearable TVS device daily; instruction and app provided.
Interventions
- Compoundvia Other• daily
Apollo wearable TVS (10–200 Hz); wear daily, at least 30 minutes after waking and at least 30 minutes before bed; intensity set at sensory threshold and adjustable by participant.
Participants
Inclusion Criteria
- Inclusion Criteria:
- Age 18 or over
- Completion of the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial (treatment cohort)
- Completion of the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial (placebo cohort)
- Enrolled in the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial, but dropped out
Exclusion Criteria
- Exclusion Criteria:
- Unable to give adequate informed consent
- Have any current problem which, in the opinion of the investigator might interfere with participation
- Are unable to complete questionnaires written in English
Study Details
- StatusUnknown status
- PhasePhase NA
- Typeinterventional
- DesignNon-randomized
- Target Enrollment200 participants
- TimelineStart: 2021-12-08End: 2025-12-31
- Topic